(15 days)
Not Found
No
The device description focuses on the light source technology (xenon and halogen lamps) and manual brightness adjustment, with no mention of AI/ML, image processing, or data sets for training/testing.
No
The device provides illumination for diagnostic and surgical procedures but does not perform any therapeutic function itself.
Yes
The device provides illumination for endoscopic diagnostic procedures, which directly contributes to the diagnostic process by enabling visualization.
No
The device description explicitly details hardware components (xenon and halogen lamps, fiber optic cable connection) and their functions, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals." This describes a device used during a medical procedure to visualize internal structures, not a device used to examine specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description focuses on the technical specifications of the light source (lamp type, wattage, brightness adjustment, color temperature, lamp life) and its connection to a fiber optic cable for illumination during procedures. There is no mention of analyzing biological samples or generating diagnostic data from them.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information based on laboratory tests
- Mentioning reagents, assays, or laboratory procedures
The device is a medical device used for illumination during endoscopic procedures, which is a clinical procedure performed on a patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
Product codes (comma separated list FDA assigned to the subject device)
GCT
Device Description
The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 5600°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 3400°K and the lamp life is approximately 50 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastroenterological and urological cavities, hollow organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Endoscopic Light sources LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) will comply with the International Standard IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) CUJ Summery/ Statement 8
510(k) CUJ Summery/ Statement for LS-3000X, LS-1800XG (Med Light X 180) and LS-2500H (Med Light H 250)
| I | Submitter |
|---|---|
| --- | ----------- |
MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 12489 Berlin Germany
- Device Names II
| 1. | Classification Name: | Accessory to an Endoscope |
|---|---|---|
| 2. | Common or Usual Name: | Endoscopic Light Source (Xenon Light Source) |
| 3. | Proprietary Name: | Endoscopic Light Source LS-3000X, LS-1800 XG |
| and LS-2500H for MGB brand | ||
| Med Light X 180 and Med light H 250 for LAWTON | ||
| brand |
Classification: III
Class II. This device is described in21 C.F.R.§876.1500: The product code for the device is GCT.
IV Predicate Device:
| name/ manufacturer: | World of Medicine Lemke GmbH |
|---|---|
| labeling: | For LS-1800XG (Med Light X 180): Endoscopic Light source XL180/L3 |
| For LS-3000X :Endoscopic Light source XL300/L5 | |
| For LS-2500H (Med Light H 250): Endoscopic Light source XL202/L3 |
V Intended Use:
The light Sources LS-3000X, LS-1800XG (Med Light X180), LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
VI Device Describtion
The Endoscopic Light Source LS-300X uses a 300W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 5600°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-1800X (Med Light X 180) uses a 180W xenon lamp to provides illumination during endoscopic diagnostic and surgical procedures through a fiber
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optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 6000°K and the lamp life is approximately 500 hours.
The Endoscopic Light Source LS-2500H (Med Light H 250) uses two 250W halogen lamps to provides illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature is approximately 3400°K and the lamp life is approximately 50 hours.
VII Substantial Equivalence
The submitted devices pose the same type of questions about safety and effectiveness as the predicate device. The new devices have no diminished safety or effectiveness. The LS-3000X is similar in design and technological characteristics to the Endoscopic Light Source XL300/L5 (K021717), the LS-1800XG (Med Light X 180) is similar in design and technological characteristics to the Endoscopic Light Source XL180/L3 (K023468) and the LS-2500H (Med Light H 250) is similar in design and technological characteristics to the Endoscopic Light Source XL202/L3 (K20889), manufactured by World of Medicine Lemke GmbH.
Both the LS-3000X, LS-1800XG (Med Light X 180), LS-2500H (Med Light H 250) and the predicate device are intended to provide illumination of body cavities, hollow organs and canals during endoscopic diagnostic and surgical procedures. In addition, both devices are designed to be used the same lamps.
The differences between the LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, MGB Endoskopische Geraete GmbH Berlin believes that the Endoscopic Light sources LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) are substantially equivalent to the predicate devices currently on the market.
VIII Performance Data
The Endoscopic Light sources LS-3000X, LS-1800X (Med Light X 180), LS-2500H (Med Light H 250) will comply with the International Standard IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 and will conform to the Medical Device Directive 93/42/EEC.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
MBG Endoskopische Geräte GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K032545
Trade/Device Name: LS-3000S; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FET Dated: August 1, 2003 Received: August 18, 2003
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for use 3
Applicant:
MGB Endoskopische Geräte GmbH Berlin
510(k) Number:
Device Name:
Endoscopic Light Source (Xenon Light Source)
LS-1800XG (for MGB brand), Med Light X 180 (for Lawton brand) LS-3000X (for MGB brand) LS-2500H (for MGB brand), Med Light H 250 (for Lawton brand)
Indications for Use:
Light Sources LS-1800XG (Med Light X180), LS-3000X, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 C.F.R. $ 801.109)
Prescription Use ✓
Nancy L. Hodgson
Division Sian Division of Reprodu and Radiological Devic 510(k) Number
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